Knee OsteoarthritisPhase 1PPPNCT03120988
Catabolic Marker Levels After Platelet Poor Plasma (PPP) Lavage
A Phase 1 study testing Lavage with Platelet Poor Plasma (PPP) in people with Knee Osteoarthritis, run by Regenexx, LLC at 1 site in United States.
Trial summary
The purpose of this study is to understand how the components of osteoarthritic knee joint fluid (synovial fluid) change after lavage treatment with platelet poor plasma. Additionally, the study participants will complete outcome questionnaire surveys before and after the treatment in conjunction with when synovial… Read more about this study
- Who is it for?
- Ages 35 to 85 years
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- Lavage with Platelet Poor Plasma (PPP)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2016to Dec 2017
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1) Voluntary signature of the institutional review board approved Informed Consent
- 2) Male or female ages 35-85
- 3) Pain, swelling, and/or functional disability in the affected knee consistent with osteoarthritis in the knee joint
- 4) Physical examination consistent with osteoarthritis as observed on imaging
- 5) Unilateral or bilateral Kellgren-Lawrence grade 3 or greater knee osteoarthritis (moderate to severe OA) and/or diagnostic MRI imaging of the affected knee showing osteoarthritis (i.e. chondral loss, fissuring, defect, bone marrow lesion, meniscus tear, synovial thickening, etc…)
- 6) Mild effusion upon ultrasound evaluation.
- 7) Is independent, ambulatory, and can comply with all postoperative evaluations and visits
Who cannot join
- 1) Knee injections of any type within 3 months prior to the study.
- 2) Knee surgery within 6 months prior to the study.
- 3) Inflammatory or auto-immune based joint diseases or other lower extremity pathology (e.g., rheumatoid arthritis, systemic lupus erythematosus, psoriatic arthritis, polymyalgia, polymyositis, gout pseudogout)
- 4) Quinolone or Statin induced myopathy/tendinopathy
- 5) Severe neurogenic inflammation of the cutaneous nerves about the knee or thigh
- 6) Contraindications for MRI
Show all 15Show fewer
- 7) Condition represents a worker's compensation case
- 8) Currently involved in a health-related litigation procedure
- 9) Is pregnant
- 10) Bleeding disorders
- 11) Currently taking anticoagulant or immunosuppressive medication
- 12)Allergy or intolerance to study medication
- 13)Use of chronic opioid
- 14)Documented history of drug abuse within six months of treatment
- 15)Any other condition, that in the opinion of the investigator, that would preclude the patient from enrollment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessing Catabolic Marker Levels in the Knee Synovial Fluid Microenvironment After Lavage With Platelet Poor Plasma (PPP)
The purpose of this study is to understand how the components of osteoarthritic knee joint fluid (synovial fluid) change after lavage treatment with platelet poor plasma. Additionally, the study participants will complete outcome questionnaire surveys before and after the treatment in conjunction with when synovial fluid is removed from the knee (2, 4, and 6 weeks after lavage). This data will help determine if the treatment of an osteoarthritic knee joint with platelet poor plasma lavage is a suitable stand-alone therapy or to improve outcome by preparing a patient's knee for further regenerative therapies.
Read the detailed description
The objective of this study is to quantify the levels of catabolic markers in osteoarthritic (OA) knee synovial fluid microenvironment (ME) before lavage treatment with platelet poor plasma (PPP) and to determine whether the anti-catabolic capabilities of the PPP are sustainable or if the diseased synovial fluid returns to pre-lavage catabolic marker levels within the 6 week period of the study.
This data will be used to determine if treatment of a diseased (OA) knee with PPP lavage would be a suitable therapy for knee OA patients either as a stand-alone treatment or to improve outcome by preparing a patient's knee microenvironment for further treatment with cellular therapies. Incidence of post-operative complications, adverse events, re-injections, and surgical intervention; change in pain score will be considered while determining these direct and indirect associations upon completion of the PPP lavage treatment. Correlation of subject reported clinical outcomes for the PPP lavage treatment will be evaluated to determine whether the treatment provides beneficial clinical outcomes.
- Conditions
- Knee Osteoarthritis
- Being tested
- Lavage with Platelet Poor Plasma (PPP)
- Keywords
- Knee OA, lavage, Platelet Poor Plasma (PPP)
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lavage with Platelet Poor Plasma (PPP)Biological
Lavage of 50cc PPP
| Study group | Role | What they receive |
|---|---|---|
| Lavage with Platelet Poor Plasma (PPP) | Experimental | Lavage using 50 cc of PPP in the knee joint. Using visual guidance, the PPP lavage will be conducted, introducing a solution of platelet poor plasma into the knee joint with subsequent removal of the fluid, in effect "washing out" the joint space. Receives: Biological: Lavage with Platelet Poor Plasma (PPP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean temporal biomarkers (pg/ml)
Measured: 4 weeks post treatment
Secondary outcomes (4)
Mean Pain Scales
Measured: 2, 4 and 6 weeks post treatment
Mean International Knee Documentation Committee Subjective Knee Evaluation
Measured: 2, 4 and 6 weeks post treatment
Complications and adverse events
Measured: 2, 4 and 6 weeks post treatment
Mean temporal biomarkers (pg/ml)
Measured: 2 and 6 weeks post treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2017
- Study startJul 2016
- Primary completion30 Jun 2017
- Study completionDec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Lavage with platelet poor plasma
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Regenexx, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Christopher Centeno, MD, Principal investigator, Regenexx and Centeno-Schultz Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03120988
- Sponsor's protocol ID
- RSI2015-LAB03
- Acronym
- PPP
- Status last verified
- Jul 2019
- First submitted
- 19 Dec 2016
- Last updated
- 17 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Centers for Disease Control and Prevention (CDC). Prevalence of doctor-diagnosed arthritis and arthritis-attributable activity limitation--United States, 2010-2012. MMWR Morb Mortal Wkly Rep. 2013 Nov 8;62(44):869-73.
PubMed 24196662Lawrence RC, Felson DT, Helmick CG, Arnold LM, Choi H, Deyo RA, Gabriel S, Hirsch R, Hochberg MC, Hunder GG, Jordan JM, Katz JN, Kremers HM, Wolfe F; National Arthritis Data Workgroup. Estimates of the prevalence of arthritis and other rheumatic conditions in the United States. Part II. Arthritis Rheum. 2008 Jan;58(1):26-35. doi: 10.1002/art.23176.
PubMed 18163497Waimann CA, Fernandez-Mazarambroz RJ, Cantor SB, Lopez-Olivo MA, Zhang H, Landon GC, Siff SJ, Suarez-Almazor ME. Cost-effectiveness of total knee replacement: a prospective cohort study. Arthritis Care Res (Hoboken). 2014 Apr;66(4):592-9. doi: 10.1002/acr.22186.
PubMed 24124052Katz JN, Brophy RH, Chaisson CE, de Chaves L, Cole BJ, Dahm DL, Donnell-Fink LA, Guermazi A, Haas AK, Jones MH, Levy BA, Mandl LA, Martin SD, Marx RG, Miniaci A, Matava MJ, Palmisano J, Reinke EK, Richardson BE, Rome BN, Safran-Norton CE, Skoniecki DJ, Solomon DH, Smith MV, Spindler KP, Stuart MJ, Wright J, Wright RW, Losina E. Surgery versus physical therapy for a meniscal tear and osteoarthritis. N Engl J Med. 2013 May 2;368(18):1675-84. doi: 10.1056/NEJMoa1301408. Epub 2013 Mar 18.
PubMed 23506518Getgood A, Collins B, Slynarski K, Kurowska E, Parker D, Engebretsen L, MacDonald PB, Litchfield R. Short-term safety and efficacy of a novel high tibial osteotomy system: a case controlled study. Knee Surg Sports Traumatol Arthrosc. 2013 Jan;21(1):260-9. doi: 10.1007/s00167-011-1709-4. Epub 2011 Oct 18.
PubMed 22005964Goldring MB, Otero M. Inflammation in osteoarthritis. Curr Opin Rheumatol. 2011 Sep;23(5):471-8. doi: 10.1097/BOR.0b013e328349c2b1.
PubMed 21788902Wang S, Wei X, Zhou J, Zhang J, Li K, Chen Q, Terek R, Fleming BC, Goldring MB, Ehrlich MG, Zhang G, Wei L. Identification of alpha2-macroglobulin as a master inhibitor of cartilage-degrading factors that attenuates the progression of posttraumatic osteoarthritis. Arthritis Rheumatol. 2014 Jul;66(7):1843-53. doi: 10.1002/art.38576.
PubMed 24578232Rehman AA, Ahsan H, Khan FH. alpha-2-Macroglobulin: a physiological guardian. J Cell Physiol. 2013 Aug;228(8):1665-75. doi: 10.1002/jcp.24266.
PubMed 23086799Irrgang JJ, Anderson AF, Boland AL, Harner CD, Neyret P, Richmond JC, Shelbourne KD; International Knee Documentation Committee. Responsiveness of the International Knee Documentation Committee Subjective Knee Form. Am J Sports Med. 2006 Oct;34(10):1567-73. doi: 10.1177/0363546506288855. Epub 2006 Jul 26.
PubMed 16870824
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing Catabolic Marker Levels in the Knee Synovial Fluid Microenvironment After Lavage With Platelet Poor Plasma (PPP)
- ClinicalTrials.gov ID
- NCT03120988
- Acronym / sponsor ID
- PPP / RSI2015-LAB03
- Conditions
- Knee Osteoarthritis
- Keywords
- Knee OA, lavage, Platelet Poor Plasma (PPP)
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Regenexx, LLCIndustry (pharma, biotech, devices)
- Study start
- Jul 2016
- Primary completion
- 30 Jun 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 19 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to understand how the components of osteoarthritic knee joint fluid (synovial fluid) change after lavage treatment with platelet poor plasma. Additionally, the study participants will complete outcome questionnaire surveys before and after the treatment in conjunction with when synovial fluid is removed from the knee (2, 4, and 6 weeks after lavage). This data will help determine if the treatment of an osteoarthritic knee joint with platelet poor plasma lavage is a suitable stand-alone therapy or to improve outcome by preparing a patient's knee for further regenerative therapies.
Detailed description
The objective of this study is to quantify the levels of catabolic markers in osteoarthritic (OA) knee synovial fluid microenvironment (ME) before lavage treatment with platelet poor plasma (PPP) and to determine whether the anti-catabolic capabilities of the PPP are sustainable or if the diseased synovial fluid returns to pre-lavage catabolic marker levels within the 6 week period of the study.
This data will be used to determine if treatment of a diseased (OA) knee with PPP lavage would be a suitable therapy for knee OA patients either as a stand-alone treatment or to improve outcome by preparing a patient's knee microenvironment for further treatment with cellular therapies. Incidence of post-operative complications, adverse events, re-injections, and surgical intervention; change in pain score will be considered while determining these direct and indirect associations upon completion of the PPP lavage treatment. Correlation of subject reported clinical outcomes for the PPP lavage treatment will be evaluated to determine whether the treatment provides beneficial clinical outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Lavage with platelet poor plasma
| Arm | Type | Receives |
|---|---|---|
| Lavage with Platelet Poor Plasma (PPP) | Experimental | Biological: Lavage with Platelet Poor Plasma (PPP)Lavage using 50 cc of PPP in the knee joint. Using visual guidance, the PPP lavage will be conducted, introducing a solution of platelet poor plasma into the knee joint with subsequent removal of the fluid, in effect "washing out" the joint space. |
Who may qualify
- Ages
- 35 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 1) Voluntary signature of the institutional review board approved Informed Consent
- 2) Male or female ages 35-85
- 3) Pain, swelling, and/or functional disability in the affected knee consistent with osteoarthritis in the knee joint
- 4) Physical examination consistent with osteoarthritis as observed on imaging
- 5) Unilateral or bilateral Kellgren-Lawrence grade 3 or greater knee osteoarthritis (moderate to severe OA) and/or diagnostic MRI imaging of the affected knee showing osteoarthritis (i.e. chondral loss, fissuring, defect, bone marrow lesion, meniscus tear, synovial thickening, etc…)
Key exclusion criteria (15 listed)
- 1) Knee injections of any type within 3 months prior to the study.
- 2) Knee surgery within 6 months prior to the study.
- 3) Inflammatory or auto-immune based joint diseases or other lower extremity pathology (e.g., rheumatoid arthritis, systemic lupus erythematosus, psoriatic arthritis, polymyalgia, polymyositis, gout pseudogout)
- 4) Quinolone or Statin induced myopathy/tendinopathy
- 5) Severe neurogenic inflammation of the cutaneous nerves about the knee or thigh
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lavage with Platelet Poor Plasma (PPP)Lavage of 50cc PPP | Biological | Lavage with Platelet Poor Plasma (PPP) |
Primary outcome
Mean temporal biomarkers (pg/ml)
Time frame: 4 weeks post treatment
4 secondary outcomes
Mean Pain Scales
Time frame: 2, 4 and 6 weeks post treatment
Mean International Knee Documentation Committee Subjective Knee Evaluation
Time frame: 2, 4 and 6 weeks post treatment
Complications and adverse events
Time frame: 2, 4 and 6 weeks post treatment
Mean temporal biomarkers (pg/ml)
Time frame: 2 and 6 weeks post treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2019.
- Background: PubMed 24196662Centers for Disease Control and Prevention (CDC). Prevalence of doctor-diagnosed arthritis and arthritis-attributable activity limitation--United States, 2010-2012. MMWR Morb Mortal Wkly Rep. 2013 Nov 8;62(44):869-73.
- Background: PubMed 18163497Lawrence RC, Felson DT, Helmick CG, Arnold LM, Choi H, Deyo RA, Gabriel S, Hirsch R, Hochberg MC, Hunder GG, Jordan JM, Katz JN, Kremers HM, Wolfe F; National Arthritis Data Workgroup. Estimates of the prevalence of arthritis and other rheumatic conditions in the United States. Part II. Arthritis Rheum. 2008 Jan;58(1):26-35. doi: 10.1002/art.23176.
- Background: PubMed 24124052Waimann CA, Fernandez-Mazarambroz RJ, Cantor SB, Lopez-Olivo MA, Zhang H, Landon GC, Siff SJ, Suarez-Almazor ME. Cost-effectiveness of total knee replacement: a prospective cohort study. Arthritis Care Res (Hoboken). 2014 Apr;66(4):592-9. doi: 10.1002/acr.22186.
- Background: PubMed 23506518Katz JN, Brophy RH, Chaisson CE, de Chaves L, Cole BJ, Dahm DL, Donnell-Fink LA, Guermazi A, Haas AK, Jones MH, Levy BA, Mandl LA, Martin SD, Marx RG, Miniaci A, Matava MJ, Palmisano J, Reinke EK, Richardson BE, Rome BN, Safran-Norton CE, Skoniecki DJ, Solomon DH, Smith MV, Spindler KP, Stuart MJ, Wright J, Wright RW, Losina E. Surgery versus physical therapy for a meniscal tear and osteoarthritis. N Engl J Med. 2013 May 2;368(18):1675-84. doi: 10.1056/NEJMoa1301408. Epub 2013 Mar 18.
- Background: PubMed 22005964Getgood A, Collins B, Slynarski K, Kurowska E, Parker D, Engebretsen L, MacDonald PB, Litchfield R. Short-term safety and efficacy of a novel high tibial osteotomy system: a case controlled study. Knee Surg Sports Traumatol Arthrosc. 2013 Jan;21(1):260-9. doi: 10.1007/s00167-011-1709-4. Epub 2011 Oct 18.
- Background: PubMed 21788902Goldring MB, Otero M. Inflammation in osteoarthritis. Curr Opin Rheumatol. 2011 Sep;23(5):471-8. doi: 10.1097/BOR.0b013e328349c2b1.
- Background: PubMed 24578232Wang S, Wei X, Zhou J, Zhang J, Li K, Chen Q, Terek R, Fleming BC, Goldring MB, Ehrlich MG, Zhang G, Wei L. Identification of alpha2-macroglobulin as a master inhibitor of cartilage-degrading factors that attenuates the progression of posttraumatic osteoarthritis. Arthritis Rheumatol. 2014 Jul;66(7):1843-53. doi: 10.1002/art.38576.
- Background: PubMed 23086799Rehman AA, Ahsan H, Khan FH. alpha-2-Macroglobulin: a physiological guardian. J Cell Physiol. 2013 Aug;228(8):1665-75. doi: 10.1002/jcp.24266.
- Background: PubMed 16870824Irrgang JJ, Anderson AF, Boland AL, Harner CD, Neyret P, Richmond JC, Shelbourne KD; International Knee Documentation Committee. Responsiveness of the International Knee Documentation Committee Subjective Knee Form. Am J Sports Med. 2006 Oct;34(10):1567-73. doi: 10.1177/0363546506288855. Epub 2006 Jul 26.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christopher Centeno, MD principal investigator
Regenexx and Centeno-Schultz Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Lavage with Platelet Poor Plasma (PPP) in people with Knee Osteoarthritis, run by Regenexx, LLC at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean temporal biomarkers (pg/ml) (time frame: 4 weeks post treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03120988, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jul 2019.